Creating a database and biobank for patients with lacunar strokes
Official title: Constitution of a Clinico-radiological Database and a Biobank for Patients With Lacunar Infarcts at Lariboisière Fernand-Widal and Sainte Anne Hospitals
Run by Assistance Publique - Hôpitaux de Paris · NCT03552926 · Data updated 2026-11-12
This study is trying to create a database and biobank for people who have had recent lacunar strokes to see if certain health markers can help predict their recovery and future health issues.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | June 6, 2018 |
| Main results expected | August 30, 2022 |
| Study ends | August 30, 2027 |
| Registry record updated | May 2, 2022 |
| Trial ID | NCT03552926 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have experienced a recent small subcortical infarct.
✕Probably not a fit
Patients with a prior diagnosis of dementia or severe disability may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to establish a clinico-radiological database and biobank for patients who have experienced recent lacunar strokes, specifically within 15 days of the event. It will focus on identifying clinical, radiological, and genetic markers that predict outcomes such as recurrent strokes, cognitive impairment, dementia, depression, gait disturbances, and overall disability. The study will involve comprehensive assessments and follow-ups to gather data on these patients' natural history and health trajectories.
Why it matters
Potential benefit: If successful, this study could enhance understanding of lacunar strokes and improve patient management and outcomes.
How similar studies have gone: While similar studies have explored cognitive outcomes in stroke patients, this specific approach to creating a biobank and database for lacunar strokes is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years and above * History of recent (less than 15 days) neurological deficit related to a small subcortical infarct (evidenced by medical history or physical examination) * Diagnosis of recent small subcortical infarct on MRI (hyperintensity on diffusion-weighted imaging showing an infarction in the territory of one perforating artery) presumably responsible for the corresponding neurological deficit * Lesion diameter mess than 20 mm * Ability to comply with scheduled follow-up and annual neurological evaluation * Affiliation to the national French health insurance (sécurité sociale) * Signature of informed consent Exclusion Criteria: * Prior diagnosis of dementia according to DSM IV criteria * Prior severe disability with Rankin scale ≥ 4 * Serious concomitant systemic disorder that can compromise the follow-up study; * Leukoencephalopathy of non-vascular origin; * Severe psychiatric disorder; * Inability to obtain an informed signed consent from the patient or his/her family; * Medical contraindication or refusal to undergo cerebral magnetic resonance scanning (MRI).
Where it's running
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Hôpital Lariboisière
Paris, France Recruiting
Study contacts
- Principal investigator: Eric JOUVENT, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Eric JOUVENT, MD, PhD
- Email: eric.jouvent@aphp.fr
- Phone: 33 1 49 95 65 29
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.